Not all excipients are inert substances; some have been shown to be potential toxicants. The Federal Food, Drug, and Cosmetic Act of 1938 (the Act) was enacted after the tragedy of the elixir of sulfanilamide in 1937 in which an untested excipient was responsible for the death of many children who consumed the pharmaceutical. The Act required manufacturers to perform safety testing of pharmaceuticals and submit new drug applications (NDAs) demonstrating safety before marketing. Since that time, the Agency has become aware that certain other excipients used in commerce can cause serious toxicities in consumers of prescription and over-the-counter (OTC) drug products in the United States and other countries and constituted a guidance in 2025, good to review what submission data is required for OTC, new drugs or BLA ; also based on short, medium and long term use.
Good guidance to review
Guidance for Industry (fda.gov)
The tragic story of Sulfanilamide poisoning is detailed here, is interesting story to offer historical perspective on why such guidance is available for excipients now
Sulfanilamide Disaster | FDA
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Sandip Tiwari
Head of Technical Services, Pharma Solutions, NA
BASF Corporation
Tarrytown NY
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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